Device Classification Name |
electrocardiograph
|
510(k) Number |
K861850 |
Device Name |
BURDICK DIVISION (E-500) |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
TIMOTHY C MICKELSON |
Correspondent |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Correspondent Contact |
TIMOTHY C MICKELSON |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 05/14/1986 |
Decision Date | 08/28/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|